FDA product code · Cardiovascular

Adjunctive Heart Failure Status Indicator

Name: FDA decisions, review times, recalls and adverse event reports for product code QUO
Creator: 510(k) Report

QUOClass II21 CFR 870.2200510(k) required4 decisions since 20220 recalls

4 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 238 days (half between 183 and 269). No recall names this code. The most-cited predicate is K222463, named by 5 later devices.

The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of QUO at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QUO

1in 2025

2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QUO

Too few QUO 510(k)s in any year since 2007 to give a median.

Recalls per year · QUO

No recall names QUO since 2007.

Adverse event reports per year · QUO

No MAUDE report names QUO since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	0
2023	1	—	0
2024	1	—	0
2025	1	—	0
2026	0	—	—

FIG. 1 — QUO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QUO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 870.2200.

PPW Adjunctive Cardiovascular Status Indicator QXZ Adjunctive Epicardial Vascular Physiologic…SDJ Adjunctive Cardiac Amyloidosis Status Indicator

Adjunctive Heart Failure Status Indicator

Which predicates do QUO devices cite most?

Which QUO devices have the deepest lineage?

What has FDA decided in QUO lately?

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